Identity
- Trade Name
- HCS FDA UDI
- Generic Name
- Electrode conductive skin pad, single-use FDA UDI
- Model / Reference
- HCS9101-50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849027002662 FDA UDI
- 510(k) Number
- K041954 FDA UDI
- FDA Product Code
- DRX FDA UDI
- GMDN Term
- Electrode conductive skin pad, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrode conductive skin pad, single-use
Hcs by Dyad Medical Sourcing, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041954 also covers:
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
- HCS — DYAD MEDICAL SOURCING, LLC
- HCS — DYAD MEDICAL SOURCING, LLC
- HCS — DYAD MEDICAL SOURCING, LLC
- HCS — DYAD MEDICAL SOURCING, LLC
- Henry Schein — HENRY SCHEIN, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- ViaMed — RECE INTERNATIONAL CORP.
- ViaMed — RECE INTERNATIONAL CORP.
- ViaMed — RECE INTERNATIONAL CORP.
- ViaMed — RECE INTERNATIONAL CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dyad Medical Sourcing, Llc
Sources (1)
- FDA UDI 9ace0d63-a92e-431d-ada9-76c8c556688b 33 fields · synced May 30, 2026